Mylotarg

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Mylotarg

This product's label may have been revised after this insert was used in production.
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Mylotarg (gemtuzumab ozogamicin for injection) should be administered under the supervision of physicians experienced
in the treatment of acute leukemia and in facilities equipped to monitor and
treat leukemia patients.

There are no controlled trials demonstrating efficacy and safety using Mylotarg (gemtuzumab ozogamicin for injection)
in combination with other chemotherapeutic agents. Therefore, Mylotarg (gemtuzumab ozogamicin for injection) should
only be used as single agent chemotherapy and not in combination chemotherapy
regimens outside clinical trials.

Severe myelosuppression occurs when Mylotarg (gemtuzumab ozogamicin for injection) is used at recommended doses.

Mylotarg (gemtuzumab ozogamicin for injection) administration can result in severe hypersensitivity reactions (including
anaphylaxis), and other infusion-related reactions which may include severe
pulmonary events. Infrequently, hypersensitivity reactions and pulmonary events
have been fatal. In most cases, infusion-related symptoms occurred during the
infusion or within 24 hours of administration of Mylotarg (gemtuzumab ozogamicin for injection) and resolved. Mylotarg (gemtuzumab ozogamicin for injection)
infusion should be interrupted for patients experiencing dyspnea or clinically
significant hypotension. Patients should be monitored until signs and symptoms
completely resolve. Discontinuation of Mylotarg (gemtuzumab ozogamicin for injection) treatment should be strongly
considered for patients who develop anaphylaxis, pulmonary edema, or acute respiratory
distress syndrome. Since patients with high peripheral blast counts may be at
greater risk for pulmonary events and tumor lysis syndrome, physicians should
consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral
white count to below 30,000/µL prior to administration of Mylotarg. (See
WARNINGS.)

HEPATOTOXICITY

Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has
been reported in association with the use of Mylotarg (gemtuzumab ozogamicin for injection) as a single agent, as
part of a combination chemotherapy regimen, and in patients without a history
of liver disease or hematopoietic stem cell transplant (HSCT). Patients who
receive Mylotarg (gemtuzumab ozogamicin for injection) either before or after HSCT, patients with underlying hepatic
disease or abnormal liver function, and patients receiving Mylotarg (gemtuzumab ozogamicin for injection) in combinations
with other chemotherapy are at increased risk for developing VOD, including
severe VOD. Death from liver failure and from VOD has been reported in patients
who received Mylotarg (gemtuzumab ozogamicin for injection) . Physicians should monitor their patients carefully
for symptoms of hepatotoxicity, particularly VOD. These symptoms can include:
rapid weight gain, right upper quadrant pain, hepatomegaly, ascites, elevations
in bilirubin and/or liver enzymes. However, careful monitoring may not identify
all patients at risk or prevent the complications of hepatotoxicity. (See
WARNINGS and ADVERSE
REACTIONS sections.)

DRUG DESCRIPTION

Mylotarg® (gemtuzumab ozogamicin for Injection) is a chemotherapy agent
composed of a recombinant humanized IgG4, kappa antibody conjugated with a cytotoxic
antitumor antibiotic, calicheamicin, isolated from fermentation of a bacterium,
Micromonospora echinospora subsp. calichensis. The antibody portion
of Mylotarg (gemtuzumab ozogamicin for injection) binds specifically to the CD33 antigen, a sialic acid-dependent
adhesionprotein found on the surface of leukemic blasts and immature normal
cells of myelomonocytic lineage, but not on normal hematopoietic stem cells.

The anti-CD33 hP67.6 antibody is produced by mammalian cell suspension culture
using a myeloma NS0 cell line and is purified under conditions which remove
or inactivate viruses. Three separate and independent steps in the hP67.6 antibody
purification process achieves retrovirus inactivation and removal. These include
low pH treatment, DEAE-Sepharose chromatography, and viral filtration. Mylotarg (gemtuzumab ozogamicin for injection)
contains amino acid sequences of which approximately 98.3% are of human origin.
The constant region and framework regions contain human sequences while the
complementarity-determining regions are derived from a murine antibody (p67.6)
that binds CD33. This antibody is linked to N-acetyl-gamma calicheamicin via
a bifunctional linker. Gemtuzumab ozogamicin has approximately 50% of the antibody
loaded with 4-6 moles calicheamicin per mole of antibody. The remaining 50%
of the antibody is not linked to the calicheamicin derivative. Gemtuzumab ozogamicin
has a molecular weight of 151 to 153 kDa.

Mylotarg (gemtuzumab ozogamicin for injection) is a sterile, white, preservative-free lyophilized powder containing
5 mg of drug conjugate (protein equivalent) in an amber vial. The drug product
is light sensitive and must be protected from direct and indirect sunlight and
unshielded fluorescent light during the preparation and administration of the
infusion. The inactive ingredients are: dextran 40; sucrose; sodiumchloride;
monobasic and dibasic sodium phosphate.

What are the possible side effects of gemtuzumab (Mylotarg)?

Some people receiving a gemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have fever, chills, or trouble breathing within 24 hours after receiving the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.